Regulatory Coordinator

Advarra, Inc.; California (MO); On-site; USD 40,000 - 60,000; Part time

Job summary

Advarra, Inc. is seeking a part-time Regulatory Coordinator in California. This role ensures compliance with regulatory requirements and Good Clinical Practice (GCP), managing IRB submissions and overseeing studies from initiation to closure.

The ideal candidate has a Bachelor’s degree with relevant experience, strong communication skills, and a background in regulatory compliance. Join us to help advance clinical research for better health outcomes.

Qualifications

• Bachelor’s degree with 3+ years of relevant experience OR associate’s degree with 4+ years of experience.
• Demonstrated experience with an electronic regulatory filing system.
• Current training in human subjects protection education, Good Clinical Practice, and HIPAA Privacy.

Responsibilities

• Analyze and implement applicable regulatory requirements and institutional policies.
• Ensure adherence to Good Clinical Practice (GCP) standards across all phases of clinical research.
• Coordinate the submission and review process for study protocols by the IRB.

Skills

Regulatory compliance

Good Clinical Practice (GCP)

Interpersonal skills

Communication skills

Organizational skills

Education

Bachelor’s degree

Associate’s degree

Tools

Electronic regulatory filing system

Job description

Location

This role is open to candidates working onsite in the Los Angeles, California area.

Company Information

At Advarra, we seek to foster an inclusive and collaborative environment where everyone is treated with respect and diverse perspectives are embraced. Treating one another, our clients, and clinical trial participants with empathy and care are key tenets of our culture at Advarra; we are committed to creating a workplace where each person is not only valued but empowered to thrive and make a meaningful impact.

Company Culture

Our people--both employees and consultants—are the heart of Advarra. They are the key to our success and the driving force behind our mission and vision. Our values (Patient-Centric, Ethical, Quality Focused, Collaborative) guide our actions and decisions. Knowing the impact of our work on trial participants and patients, we act with urgency and purpose to advance clinical research so that people can live happier, healthier lives.

Job Overview Summary

The part‑time Regulatory Coordinator ensures compliance with regulatory requirements and Good Clinical Practice (GCP) standards in clinical research. This role manages IRB submissions and oversees studies from initiation through closure, ensuring regulatory integrity while supporting investigators and research staff.

Job Duties & Responsibilities

• Analyzes and implements applicable regulatory requirements, institutional policies, and guidance documents to ensure the protection, welfare, and safety of research participants.
• Ensures adherence to Good Clinical Practice (GCP) standards across all phases of clinical research.
• Coordinates the submission and review process for study protocols, amendments, continuing reviews, and reportable events by the Institutional Review Board (IRB), from study initiation through closure.

Basic Qualifications

• Bachelor’s degree with 3+ years of relevant experience OR associate’s degree with 4+ years of experience.
• Demonstrated experience with an electronic regulatory filing system.
• Current training in human subjects protection education, Good Clinical Practice, and HIPAA Privacy.

Preferred Qualifications

• Strong interpersonal and client interaction skills.
• Strong communication and organization skills.
• Certified Clinical Research Professional (CCRP)/Certified Clinical Research Coordinator (CCRC)/Society of Clinical Research Associates (SOCRA) or equivalent preferred.

Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.